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Quality Assurance Specialist
Job in
Irvine, Orange County, California, 92713, USA
Listed on 2026-02-07
Listing for:
Indotronix Avani Group
Full Time
position Listed on 2026-02-07
Job specializations:
-
Healthcare
Data Scientist -
Quality Assurance - QA/QC
Data Analyst
Job Description & How to Apply Below
Overview
Responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective. Generally matched to Quality Assurance in surveys.
Qualifications- Preferred Bachelor’s degree in Engineering, Computer Science, Heath Science
- Minimum of 2 years experience in Medical Device, Life Sciences or Healthcare industry
- Expertise in extracting, filtering, validating and downloading data from Power BI
- Expertise in manipulating, and analyzing large datasets using advanced excel functions and formulas (VLOOKUP, pivot tables, conditional formulas)
- Preferred experience with ETQ Quality Management System
- Experience in the post-market surveillance area (review of data and relationship to complaints)
- Understand the importance of quality compliance with medical device industry data.
- Knowledge of applicable FDA regulations for medical device industry (CFR, ISO standards)
- Experience in Track Wise QMS a plus
- Needs to be a quick learner. Used to working in a tight deadline environment. Highly organized.
- Usage of Power Point, Excel, Word
- Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills
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